Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure

Paul Hauptman, Mark A. Schnitzler, Jason Swindle, Thomas E. Burroughs

Research output: Contribution to journalArticle

48 Citations (Scopus)

Abstract

Context: The rate of adoption of new therapies for cardiovascular diseases following the publication of favorable clinical trial results has been studied; however, less is known about the rates of de-adoption of a drug when negative studies are published. Objective: To evaluate the use of nesiritide before and after March and April 2005 publications in 2 high-impact journals that suggested an increased risk of renal failure and mortality with intravenous nesiritide for acute decompensated heart failure. Design, Setting, and Patients: Analysis of a large prospective hospital database, developed for quality and utilization benchmarking, of 491 acute care US hospitals at which 385 627 inpatient admissions occurred with a primary International Classification of Diseases, Ninth Revision (ICD-9) code for heart failure between January and August 2001 (prior to nesiritide release) and January 2004 to December 2005 (before and after publication periods). In addition, any patient admitted who received nesiritide in the absence of a primary or secondary heart failure code was evaluated for potential off-label use of the drug. Main Outcome Measure: Use of nesiritide and other intravenous vasoactive therapy among patients admitted with heart failure. Results: Nesiritide use decreased from a peak of 16.6% (2351 of 14 167 admissions) in March 2005 to 5.6% (611 of 10 822 admissions) in December 2005 (P<.001). Among those patients treated with nesiritide, the mean duration of treatment changed minimally, from 2.3 to 2.1 days. Although the use of inotropes also decreased during the period under study, the changes were more modest; furthermore, of those patients who were prescribed intravenous vasoactive therapy, a higher percentage were prescribed inotropes after publication (3272 [21.5%] of 15 193 patients from January-April 2005 vs 5750 [29.6%] of 19 445 patients from May-December 2005, P<.001). The use of nesiritide, in the absence of an ICD-9 heart failure code, was small. Conclusions: Rapid de-adoption of nesiritide occurred following 2 publications suggesting risk with the drug. Further analyses are required to evaluate the consequences of these changes on patient outcomes and to anticipate how publications of adverse findings can influence practice.

Original languageEnglish (US)
Pages (from-to)1877-1884
Number of pages8
JournalJournal of the American Medical Association
Volume296
Issue number15
DOIs
StatePublished - Oct 18 2006
Externally publishedYes

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Brain Natriuretic Peptide
Publications
Heart Failure
International Classification of Diseases
Pharmaceutical Preparations
Off-Label Use
Benchmarking
Therapeutics
Renal Insufficiency
Inpatients
Cardiovascular Diseases
Outcome Assessment (Health Care)
Clinical Trials
Databases
Mortality

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure. / Hauptman, Paul; Schnitzler, Mark A.; Swindle, Jason; Burroughs, Thomas E.

In: Journal of the American Medical Association, Vol. 296, No. 15, 18.10.2006, p. 1877-1884.

Research output: Contribution to journalArticle

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abstract = "Context: The rate of adoption of new therapies for cardiovascular diseases following the publication of favorable clinical trial results has been studied; however, less is known about the rates of de-adoption of a drug when negative studies are published. Objective: To evaluate the use of nesiritide before and after March and April 2005 publications in 2 high-impact journals that suggested an increased risk of renal failure and mortality with intravenous nesiritide for acute decompensated heart failure. Design, Setting, and Patients: Analysis of a large prospective hospital database, developed for quality and utilization benchmarking, of 491 acute care US hospitals at which 385 627 inpatient admissions occurred with a primary International Classification of Diseases, Ninth Revision (ICD-9) code for heart failure between January and August 2001 (prior to nesiritide release) and January 2004 to December 2005 (before and after publication periods). In addition, any patient admitted who received nesiritide in the absence of a primary or secondary heart failure code was evaluated for potential off-label use of the drug. Main Outcome Measure: Use of nesiritide and other intravenous vasoactive therapy among patients admitted with heart failure. Results: Nesiritide use decreased from a peak of 16.6{\%} (2351 of 14 167 admissions) in March 2005 to 5.6{\%} (611 of 10 822 admissions) in December 2005 (P<.001). Among those patients treated with nesiritide, the mean duration of treatment changed minimally, from 2.3 to 2.1 days. Although the use of inotropes also decreased during the period under study, the changes were more modest; furthermore, of those patients who were prescribed intravenous vasoactive therapy, a higher percentage were prescribed inotropes after publication (3272 [21.5{\%}] of 15 193 patients from January-April 2005 vs 5750 [29.6{\%}] of 19 445 patients from May-December 2005, P<.001). The use of nesiritide, in the absence of an ICD-9 heart failure code, was small. Conclusions: Rapid de-adoption of nesiritide occurred following 2 publications suggesting risk with the drug. Further analyses are required to evaluate the consequences of these changes on patient outcomes and to anticipate how publications of adverse findings can influence practice.",
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AU - Burroughs, Thomas E.

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N2 - Context: The rate of adoption of new therapies for cardiovascular diseases following the publication of favorable clinical trial results has been studied; however, less is known about the rates of de-adoption of a drug when negative studies are published. Objective: To evaluate the use of nesiritide before and after March and April 2005 publications in 2 high-impact journals that suggested an increased risk of renal failure and mortality with intravenous nesiritide for acute decompensated heart failure. Design, Setting, and Patients: Analysis of a large prospective hospital database, developed for quality and utilization benchmarking, of 491 acute care US hospitals at which 385 627 inpatient admissions occurred with a primary International Classification of Diseases, Ninth Revision (ICD-9) code for heart failure between January and August 2001 (prior to nesiritide release) and January 2004 to December 2005 (before and after publication periods). In addition, any patient admitted who received nesiritide in the absence of a primary or secondary heart failure code was evaluated for potential off-label use of the drug. Main Outcome Measure: Use of nesiritide and other intravenous vasoactive therapy among patients admitted with heart failure. Results: Nesiritide use decreased from a peak of 16.6% (2351 of 14 167 admissions) in March 2005 to 5.6% (611 of 10 822 admissions) in December 2005 (P<.001). Among those patients treated with nesiritide, the mean duration of treatment changed minimally, from 2.3 to 2.1 days. Although the use of inotropes also decreased during the period under study, the changes were more modest; furthermore, of those patients who were prescribed intravenous vasoactive therapy, a higher percentage were prescribed inotropes after publication (3272 [21.5%] of 15 193 patients from January-April 2005 vs 5750 [29.6%] of 19 445 patients from May-December 2005, P<.001). The use of nesiritide, in the absence of an ICD-9 heart failure code, was small. Conclusions: Rapid de-adoption of nesiritide occurred following 2 publications suggesting risk with the drug. Further analyses are required to evaluate the consequences of these changes on patient outcomes and to anticipate how publications of adverse findings can influence practice.

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